Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease (Aim 2)

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
University of Nebraska
Study ID
NCT05070013
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Deep Brain Stimulation — DEVICE
    All participants will undergo three 1-week interventions of stimulation during nighttime sleep over the course of three consecutive weeks of in-home sleep: adaptive stimulation, open-loop stimulation and no stimulation.

Study Details

Parkinson's Disease (PD) is the second most common of the age-related neurodegenerative disorders, affecting over 1,900 adults per 100,000 over the age of 80 in the US. The prevalence of sleep dysfunction in PD is estimated at nearly 80-90% which includes sleep fragmentation, insomnia, rapid eye movement (REM or dream sleep) Sleep Behavior Disorder (RBD), Restless legs syndrome (RLS), periodic limb movement, excessive daytime sleepiness, and sleep apnea. Sleep is vital to homeostasis, cognition, and nervous system repair. The dysfunctional sleep accompanying PD adversely affects both motor and non-motor symptoms, resulting in diminished quality of life for both patients and caregivers, including impairments in mood and behavior, and increased morbidity and mortality. Knowledge of sleep phenomenology and pathology in humans has largely been informed by analysis of non-invasive scalp electroencephalogram (EEG), and despite the profound importance of sleep, the underlying neural circuits important for controlling sleep and wakefulness in humans remain poorly understood. This study assesses whether adaptive stimulation of the Subthalamic Nucleus (STN) drives changes in sleep episode maintenance and improves sleep quality. Participants are adults with PD who experience inadequate motor symptom relief, and who have been offered implantation of a deep brain stimulator system targeting STN for the treatment of motor symptoms (standard-of-care). Prior to surgery, participant sleep patterns will be assessed with questionnaires and monitored with a non-invasive watch-like device. Approximately four months after implantation surgery, participants will each receive 2 1-week deep brain stimulation (DBS) treatments and 1 1-week control session with no DBS in random order. Sleep patterns will again be monitored during the treatments and compared to the patterns before surgery.

Key Dates

Start date
Nov 18, 2021
Status verified
May 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Adaptive Deep Brain Stimulation
    Participants will be given adaptive deep brain stimulation (DBS) during one week of at-home night sleep.
  • Active Comparator: Open-loop Deep Brain Stimulation
    Participants will be given open-loop deep brain stimulation (DBS) (standard clinical stimulation therapy based on (DBS) programming for the treatment of motor symptoms) during one week of at-home night sleep.
  • No Intervention: No Deep Brain Stimulation
    Deep brain stimulation (DBS) is turned off (control) during one week of at-home night sleep.

Primary Outcome Measure

Sleep Efficiency - Frequency [ Time Frame: Baseline (days 1 - 21 before surgery) and intervention (approximately days 144 - 172) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Nebraska Medical CenterOmahaNebraska68198
Dulce Maroni, PhD
[email protected]
402-836-9751
Andrew Schnaubelt, PhD
[email protected]
402-559-4846
Aviva Abosch, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Pennsylvania Health SystemPhiladelphiaPennsylvania19106
NIda Firdous, MD
[email protected]
215-829-6720
Marie Kerr, CCRP
[email protected]
215-829-6720
Casey Halpern, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Omaha, NE

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
University of Nebraska Medical Center· Omaha, NEUniversity of Pennsylvania Health System· Philadelphia, PA

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